Thermo Fisher Scientific

Sr Director, Quality Large Molecule

Missouri, United States

Thermo Fisher Scientific Logo
Not SpecifiedCompensation
Expert & Leadership (9+ years)Experience Level
Full TimeJob Type
UnknownVisa
Pharmaceuticals, Biotechnology, Life SciencesIndustries

Requirements

Candidates should possess a Bachelor’s degree in business or a scientific/technical field, and a minimum of 15 years’ experience in multinational pharmaceutical/biopharmaceutical organizations with global experience, including multi-site Operations/Quality roles. Extensive cGMP knowledge is required, and previous experience with Large Molecule manufacturing is preferred. The candidate must also demonstrate the ability to optimally collaborate with others, lead, empower, and influence remote teams, and experience developing others.

Responsibilities

The Senior Director Quality, Large Molecule is responsible for ensuring medicines are manufactured safely and delivered on time, maintaining all Quality standards, regulatory requirements, and customer expectations. Key responsibilities include developing and implementing quality plans, fostering positive relationships with customers and regulators, emphasizing on-time delivery through compliance, encouraging a right-first-time culture, monitoring quality system metrics, ensuring inspection readiness, interfacing with regulatory authorities, developing resource strategies, and ensuring PPI (Practical Process Improvement) is adopted across the quality organization. The role also involves representing the company externally and managing key accounts.

Skills

Quality Management
Regulatory Compliance
Leadership
Strategic Planning
Stakeholder Engagement
Quality Policy Development

Thermo Fisher Scientific

Provides life sciences products and services

About Thermo Fisher Scientific

Thermo Fisher Scientific offers a variety of products and services that support scientific research and healthcare, including laboratory equipment, reagents, and software solutions. Their products are used in applications like protein biology, real-time PCR, and sequencing, serving clients such as academic institutions and pharmaceutical companies. Unlike competitors, Thermo Fisher emphasizes customer support and education, helping clients optimize their experiments. The company's goal is to be a leading provider of life sciences solutions that contribute to a healthier and safer world.

Key Metrics

Waltham, MassachusettsHeadquarters
1956Year Founded
$17MTotal Funding
IPOCompany Stage
Biotechnology, HealthcareIndustries
10,001+Employees

Risks

Increased competition in single-use bioprocessing may impact market share.
Sale of anatomical pathology business could create a temporary product gap.
Investment in miDiagnostics may face regulatory challenges affecting returns.

Differentiation

Thermo Fisher offers a comprehensive range of life sciences products and services.
Their well-known brands include Thermo Scientific, Applied Biosystems, and Invitrogen.
They provide strong customer support and educational resources to optimize client workflows.

Upsides

Expansion of biologics production facility enhances capacity for precision biologics monitoring.
Investment in miDiagnostics aligns with demand for rapid diagnostic solutions in BioPharma.
Collaboration with Mainz Biomed positions them in the growing cancer detection market.

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